Monday, March 2, 2015

Merck's Adam Schechter At Cowen & Co. Health Care Conference Tomorrow Morning In Boston

He's not likely to make any real news in Boston tomorrow, but we'll likely listen in just the same. [I suppose he might comment on BMS getting priority review for Opdivo®, in NSCLC -- and Merck's catch-up plans.] We may liveblog any real news:

. . . .Adam Schechter, executive vice president and president, Global Human Health, Merck, is scheduled to present at the 35th Annual Cowen Health Care Conference in Boston on Mar. 3, 2015 at 8:40 a.m. EST.

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .

So, do stop back by -- around 8:40 Eastern tomorrow morning. I doubt he'll discuss anything new and material -- but who knows?

Sunday, March 1, 2015

FDA Grants Priority Review To BMS's Opdivo® -- In Previously-Treated Lung Cancers

And with this Friday afternoon news, just as I predicted, BMS has seized the lead in a "significant burden" oncology line (NSCLC), over Merck's Keytruda®.

For its part, Merck expects to file in the first half of 2015 -- but that likely puts Merck more than six months behind BMS's Opdivo®. Just as I said over a year ago, now.

From the BMS press release, then:

. . . .BMS today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015. . . .

So. . . now Merck will be playing "catch up" in NSCLC. Ouch.

Prediction: The Supremes Will Toss King v. Burwell -- The ACA of 2010 Was Intended "To Achieve Near Universal Coverage"

This coming week, the US Supreme Court will hear oral arguments in King v. Burwell -- yet another tempest in a teapot, engineered by the hubris of a few -- who hope to undo the lawful will of. . . the many.

As most of the better legal scholars have noted -- despite much of the right-leaning hullaballoo -- this case isn't really about very much. It is yet another attempt to invalidate a central component of a 900 page statute, by positing a befuddling, and counter-intuitive reading of five words in one subsection -- a subsection that deals with calculating the AMOUNT of a subsidy; not whether the subsidy should exist at all. It is beyond serious dispute that Congress intended to create near universal coverage in passing the ACA of 2010.

And so, it is the position of many legal scholars (who follow these matters closely) that the Supremes have agreed to take the case precisely to put to a final, non-appealable death the notion that five words may ever be a place where Congress intentionally hides an elephant -- deep inside a. . . mousehole.

And the central job of the Supremes here -- having already ruled that the ACA of 2010 was a valid exercise of Congressional power -- will be to uphold the intent of the Congress in passing a valid, necessary and proper (albeit complex) 900 page statute. From the excellent amicus brief of HCA, a large Tennessee based corporate hospital chain, then -- a bit of the persuasion:

. . . .In Petitioners’ view [the parties seeking to overturn this ACA provision], however, Congress made residents of every state eligible for a subsidy, only to then deny subsidies to every resident of certain states through the application of a formula for calculating the amount of the subsidy. Specifically, because the amount of the subsidy is tied to the cost of a plan offered on an “Exchange established by the State,” id. § 36B(b)(2)(A), Petitioners argue that the calculation works out to $0 for every resident of a federally-facilitated Exchange state.

Congress does not hide “elephants” in such “mouseholes.” Whitman v. Am. Trucking Ass’ns, 531 U.S. 457, 468 (2001). No member of Congress – not to mention the millions of Americans who have relied on the promise of subsidies and are now overwhelmingly satisfied with their coverage – would have understood these five words buried in a formula as making the promise of affordable coverage illusory for large swathes of the population.

The text of the statute confirms what common sense suggests: the ACA’s subsidy-calculation provision does not have the massive import Petitioners seek to give it. Rather, the ACA’s definitions make clear that every “Exchange” is treated as “established under section 1311” – the section obligating states to establish Exchanges – even when the federal government is in fact operating the Exchange under section 1321. 42 U.S.C. § 300gg–91(d)(21). Section 1311 itself specifies that every Exchange is, by operation of law, “a governmental agency or nonprofit entity that is established by a State.” 42 U.S.C. § 18031(d)(1) (emphasis added). And in directing HHS to operate “such Exchange,” Congress confirmed that a federally-facilitated Exchange under section 1321 is still, for statutory purposes, an Exchange established by the state under section 1311. ACA § 1321, 42 U.S.C. § 18041(c)(1). Together, these provisions make clear that Congress used “Exchange established by the State” in § 36B as a statutory term of art, not as a roundabout way to deny affordable coverage to residents of states that decline to run their own Exchange. . . .

Petitioners’ interpretation cannot be accepted for the additional reason that it would “undermine in a substantial way the [statute’s] purpose.” Maracich, 133 S. Ct. at 2200. There is no need to resort to legislative history to divine the fundamental legislative purpose of the ACA, because the statute makes it plain: “achiev[ing] near-universal coverage. . . .”

The fundamental question in this case is whether the ACA is in fact “a comprehensive national plan to provide universal health insurance coverage,” NFIB, 132 S. Ct. at 2606 (2012) (op. of Roberts, C.J., joined by Breyer & Kagan, JJ.), or instead contains a trap door through which millions of Americans may fall. Every tool of statutory interpretation indicates that Congress intended the former. With subsidies available on the federally-facilitated Exchanges, the newly insured are able to take personal responsibility for their care, emergency room usage is dropping, women are gaining access to needed care, and the costs and benefits of expanding coverage are being shared throughout the health care system.

Without the subsidies, an otherwise coherent regulatory scheme may come apart at the seams: the newly insured could lose coverage, the positive trends in the delivery of care noted above could be reversed, the economic logic of the ACA could be disrupted, the federally-facilitated Exchanges could slide into dysfunction, and even the previously insured could lack access to a viable alternative market.

This Court should follow the interpretation that makes sense of the ACA’s interconnected provisions. That interpretation is that subsidies are available to every “applicable taxpayer,” without regard to whether his or her state has elected to run its own Exchange. . . .

Of course you will read much right leaning rhetoric suggesting that. . . the ACA of 2010 sky is about to fall. You may safely ignore it. You heard it here first. [A very good, plain English version of this discussion appears on the editorial pages of The New York Times, this Sunday morning, as a light silvery snow drifts down here, once again. Fly safely one and all.]

Saturday, February 28, 2015

Legacy Schering-Plough Zenhale® Inhalers Recalled -- In Canada Only

Not material to Merck overall -- but noteworthy for its legacy attachment to the Schering-Plough OTC version Nasonex® franchise.

OTC Nasonex (a product and brand now owned by Bayer -- as part of that consumer health transaction) contains some of the same active ingredient as the Zenhale product in Canada. See graphic at right. Here is the relevant Health Canada notice, in any event -- and a bit:

. . . .Merck Canada is initiating a recall of certain lots (see attached list) of Zenhale at the pharmacy/physician level due to the possibility of device malfunction after 24 months shelf-life, resulting in the potential for a patient to receive a lower dose than expected. The company’s investigation has determined that the occurrence of this defect is low.

Merck Canada expects new [inhaler] product to be available in pharmacies by March 23, 2015. Merck Canada will reduce the shelf life of all Zenhale products from 36 months to 24 months. The new product will have a shelf-life of 24 months. . . .

So it goes -- all remedied by March 23, 2015. Thus immaterial. Now, here on a snowy Saturday night -- going to catch up and see Kingsman. . . .UPDATE: it was horrific -- as in an atrocious waste of time.

Friday, February 27, 2015

WHO/SAGE Indicate "No Decision" -- On Mass Ebola Vaccinations -- Until At Least August 2015

Clearly, the recent and heartening reduction in the year long outbreak (the world's worst, thus far) is stretching the time line, but that is net, net, a good thing. And clearly we need to see the immune response is durable in the wild -- in the real world. So we will need to be patient here. I am encouraged. And I am sure Merck and New Link are, too. As are GSK and J&J.

Here's the Reuters bit, overnight:

. . . .WHO spokesman Christian Lindmeier, reporting on a three-day meeting of experts, told a news briefing: "Vaccine introduction is by no means a given and will depend on the results of clinical trials and recommendations from WHO's Strategy Advisory Group of Experts (SAGE) on vaccines and immunization.

"The earliest that the SAGE is expected to make recommendation on a wide-scale introduction is August. Decisions on whether or not to introduce the vaccine will be made by the respective ministries of health of countries. . . ."

WHO spokeswoman Margaret Harris said: "We know the vaccines are safe, we know they produce a good immunogenic response in humans, but we don't know if they are effective when you actually have disease in community."

Guinea, Liberia and Sierra Leone reported 99 new confirmed Ebola cases in the week to Feb. 22, down from 128 the previous week, the WHO said on Wednesday. . . .

So, encouraging declines in new cases continue. . . and Merck will of course "do the right, as it sees. . . the right." For my part, I'll keep hoping. . . for "hope is a good thing -- perhaps even the best of all things. . . ." Onward.

Jefferies & Co. Continues To See-Saw, On Merck

The last move from this house was up to $69 -- now back to $63 (where, in November 2014, the analysts had it prior to the "breakout" $69 level) -- so, the see-saw on near term NYSE price targets for Kenilworth continues.

Always a "Hold" -- neither a "Buy" or "Sell". . . In the context of other large cap pharma concerns -- here is the landscape, at the moment:

. . . .Jefferies Group has also taken action a number of other healthcare stocks recently. The firm raised its price target on shares of Pfizer Inc. from $40.00 to $42.00. They have a buy rating on that stock.

Also, Jefferies Group reiterated its hold rating on shares of Merck & Co., Inc.. They have a $63.00 price target on that stock, down previously from $69.00.

Finally, Jefferies Group reiterated its buy rating on shares of Eli Lilly and Co. They have a $87.00 price target on that stock, up previously from $80.00. . . .

Happy Friday, one and all. Be safe; be warm.

Thursday, February 26, 2015

The Company That Acquired Merck's Boulder Bio Operations -- Has Itself Been Acquired -- By A Trio Of Investment Companies

Back in May of 2014, we reported that KBI BioPharma had purchased Merck's microbial lines API capabilities in Boulder, Colorado. Long before that, we had reported in early-2010 that Merck had itself acquired the facilities from a third party, called Insmed (with additional nuances here).

Here's the bit from Genetic Engineering & Biotechnology News:

. . . .KBI says its capabilities include delivering expert and integrated process development and cGMP manufacturing of recombinant protein active pharmaceutical ingredients (API). Among clients offering testimonials on KBI’s website are Auxillium Pharmaceuticals (acquired by Endo International for $2.6 billion in a deal completed January 29), DynPort Vaccine (a CSC company), Elusys Therapeutics, Trans Tech Pharma, and UCB Celltech.

KBI expanded to Boulder last year, when it bought the microbial process development and manufacturing operations of Merck & Co. for an undisclosed price. As part of that acquisition, KBI agreed to provide ongoing development and manufacturing services to Merck, as well as to third-party customers. . . .

So it goes -- this Boulder bunch has a great pedigree and does excellent science. But it sure has been passed around a bit -- and on very short round-trips, too. I'm just sayin'. . .

An Update -- On Gilead's Tax Haven Utilization -- For Its Sovaldi® Juggernaut

Since we have long followed the way Gilead's Sovaldi® has all but crushed the life out of both Vertex's and Merck's last gen Hep C drugs (which were revolutionary in their day), I thought the readership might enjoy an update on how the Sovaldi train is running, ex-US.

Tonight, the Chicago Tribune has a nicely nuanced story -- about how effective Gilead has become, in sheltering its Sovaldi income from US taxation. [It shouldn't entirely escape notice, however, that Gilead's chief competitor here, Abbott Labs, calls the Chicagoland area home -- and so this is a bit of home town boosterism, in a back-handed way. Boosterism, by casting an unflattering light on Gilead's Irish haven operations.] here is a bit of the Trib story -- do read it all:

. . . .The company reported foreign income before taxes of $8.2 billion for 2014, earning more in non-U.S. profits than it recorded in non-U.S. sales. The data released in a securities filing Wednesday suggest that Gilead is taking advantage of U.S. rules that let companies shift valuable intellectual property to low-tax countries, said Robert Willens, an independent tax consultant based in New York.

"Whenever you have huge, very high profit margins and a lot of income as well, it almost always results from the exploitation of intangibles," Willens said in a telephone interview. "It's quite a dramatic increase from one year to the other. That's something you don't see very often. . . ."

When a multi-national company (with dozens of subsidiaries) records more net income -- than sales -- in a given non-US geography, it must mean that the US entities in the chain are paying a hefty patent royalty on each dollar of their own sales, in the US -- to the patent holding company (usually a parent or subsidiary in Ireland, or a Benelux jurisdiction).

This is plainly defensible for truly ground breakingly revolutionary drugs -- the heart of which rely upon extremely valuable inventions, or intellectual property -- usually patented.

So it would seem, as to Gilead. Fascinating, and good tax planning -- sez me.

NICE To Routinely Reimburse For Merck's Remicade®: United Kingdom Good News

While this expansion of coverage probably won't counter the erosion from bio-similars, it is good news for Merck's non-US operations. We will keep an eye out for Pound Sterling revenue trend lines, in the first and second quarters of 2015.

Here's a it, from PharmaTimes:

. . .Merck Sharpe & Dohme’s Remicade (infliximab) and Simponi (golimumab) and AbbVie’s Humira (adalimumab) will be routinely funded on the NHS to treat the chronic bowel condition in patients with moderate to severe disease, significantly expanding access to these biologics.

Around 146,000 people in the UK live with UC, and the new recommendation means that more options are available to patients giving them a greater chance of controlling symptoms “so they can have a much better quality of life,” said Carole Longson, NICE Health Technology Evaluation Centre Director. . . .

Onward -- out, into the snow!

Wednesday, February 25, 2015

Launch Day! -- Euro Biosimilar to Merck's Remicade®

The estimate is that over the next decade, over $100 billion of value will be transferred away from branded makers, to the bio-similar producers, in the class of biologics overall.

It begins in earnest, for Merck, today. Here is Reuters on it:

. . . .Paul Greenland, head of biologics at Hospira, said that biosimilars are likely to be priced about 20-30 percent cheaper than originals.

Because biotech drugs are made from living cells it is impossible to manufacture exact copies, as happens with simple chemical medicines, so regulators have come up with the notion of approving products that are similar enough to do the job.

Remicade, which has annual European sales of about 2 billion euros ($2.3 billion), and the two biosimilar copies all contain an antibody known as infliximab. . . .

Probably at least a 15 per cent down bubble in sales of Remicade®, over the next three years, in the EU then -- for Kenilworth. But it is priced into today's NYSE quote.

Tuesday, February 24, 2015

Once Again, Doing Well -- And Doing The Good. . . Isentress® Access For Limited Means HIV+ Children Globally

The Medicines Patent Pool announced this morning that Merck, via MSD, has granted non-exclusive licenses in up to 92 limited means countries, for pediatric raltegravir dosings.

This is both moral, and smart, business. Merck follows on the heels of its iDesign HIV Awareness and patient assistance programs with this humanitarian effort. My hat is off to the team that made it happen. From ABC News, then:

. . . .Drugmaker Merck & Co. has granted a free license allowing one of its HIV medicines to be made and sold inexpensively for use in young children in poor countries hard hit by the AIDS virus. . . .

The deal, announced Tuesday, lets any generic or brand name drug manufacturer make low-cost pediatric versions of Merck's raltegravir for sale in 92 low- and middle-income countries, according to the Medicines Patent Pool. The group, backed by the United Nations, works with brand-name drugmakers to find ways to make their HIV medicines still covered by patents available in developing countries for a fraction of the price charged in Europe or the United States. . . .

Of course, MPP officials have renewed their call for Merck to make the life-saving drug available to adults, under a similar license. I don't expect that Kenilworth will agree to that. There is just too great a risk of it being pirated, and resold in the post industrial world -- undercutting Merck's perhaps $1 billion invested in bringing Isentress® to market, globally.

Monday, February 23, 2015

Ed Silverman: New Merck's "Old School" Biotech Collaboration With NGM Bio

More later -- but this is fascinating. Up to $450 million over five years -- and a "go wherever your head & gut lead you" mandate. Amazing.

LATER UPDATE: Here is a rather breathless account of the deal's back and forth -- from Bloomberg. I'll not need to add. . . anything to that link. I guess Roger has known the NGM folks since at least 2004, at Amgen.

In any event -- from that gent, Ed, who had it first -- at Pharmalot, then:

. . . .Merck will provide a $94 million upfront payment and a $106 million equity investment for a 15% stake, and also fund $250 million of NGM R&D projects over the next five years, although NGM has full authority to control R&D. Merck R&D chief Roger Perlmutter and NGM chief scientific officer, Jin-Long Chen, by the way, once worked together at Amgen. . . .

Off to court, and other sundry duties!

Sunday, February 22, 2015

How The Mighty Have Fallen. . . Part Two: Fred Hassan Founder & Chairman Of (Wait For It. . .) A "Peppermint Oil" Company

As ever, picture is worth 1,000 words -- so I offer one, at right. And, still no clinical trial proving his delivery system provides any real world benefit over a drop or two on the tongue. [I just checked again this morning.] So, the $25 for about two weeks of supply. . . is in my opinion -- outrageous. From my earlier piece -- in June of 2014, then:

Of course. . . not all homeopathic remedies are without merit. Far from it. Some are as effective as FDA approved drugs, at a fraction of the cost. And there is some research suggesting that peppermint oils (properly delivered) might calm upset stomachs. [But I'll flat out guarantee you there is no peer reviewed research of any kind -- showing that Fred Hassan's delivery system here -- micro-beaded capsules -- actually achieves any positive clinical outcomes, beyond that of a few pennies a dose, in the form of a drop or two of ordinary peppermint oil, on the tongue. If he had it -- he'd tout it, to the high heavens! Trust that.]

So, what is truly beyond the pale, here -- in my opinion -- is the price ($25 for 48 capsules!?!), and the pseudo-science in which "Fast Fred" drapes his latest "medical food" -- actually something more akin to a nutri-ceutical, if the truth be told. But FDA is taking a hard look at nutri-ceuticals. Fast Fred is likely trying to "fly under the radar," here -- by calling it a medical food.

I might ask Fred "How many foods require that they be consumed ONLY under a doctor's close supervision?" Doesn't that contradict the idea of GRAS? How is that "generally recognized as safe"? An overdose of purified, concentrated menthol in the gut can lead to several serious side effects. No mention of those, on this slap-dash website.

As I say -- this is quite a come-down for Mr. Hassan -- yet, it does give us a very clear window, to where his head has always been: snagging the hucksters' fast buck -- then moving on, when the regulators show up. And show up, they will. [My guess is that his former GC, Sabatino, helped him get it on the shelves at Walgreens. But that's just. . . a guess. And now, Sabatino has moved on to. . . Hertz, anyway. Revolving doors. . . .]

Note that Mr. Hassan is listed (by a laughingly-inane asterisk) as the "non-executive" chairman of this joint. I am sure the others associated with this company, genuinely want to help patients. They have simply put their careers in the hands of the wrong "expert" here. Mark my words, Fred will slip away, saying he had no real responsibility for any regulatory matter, when the FDA shows up for a site visit. His openly making of a medical claim (without accompanying proof, of any kind) in the below YouTube "infomercial" (this is truly priceless -- so amateurish!) just gave FDA clear jurisdiction, trust that. [See it, at about 1:21 onward. . . in the video.] Fred is likely telling IBGard staffers that FDA has no right to come in and tell "us folks" what to do. He is just mistaken about that, in my experienced opinion.

So it goes. Pretty. . . hilarious!

Friday, February 20, 2015

Vorapaxar (Branded As Zontivity®) May Ultimately Turn Out To Be Not So Terribly Waifish, Afterall

Approved in May 2014, after manifold, multi-year delays, Zontivity® (vorapaxar) has had a bit of a bumpy ride. More background here.

But a forthcoming study in the journal Circulation may slightly improve sales for the beleaguered legacy Schering-Plough drug. [This was one of Fast Fred's 2008-2009 "five stars". . . that became a "has been," before it "ever was". Almost a "never was," in fact.] It seems the PAR-1 inhibitor is showing some moderate efficacy in diabetic patients with a prior history of MI (without -- thus far -- undue breakthrough bleeds). And that is not a small population, either. Here's the snippet:

. . . .Patients with diabetes who have had an MI are at particularly increased risk for recurrent ischemic events, but a new study published online February 13, 2015, ahead of print in Circulation suggests that the addition of the novel antiplatelet agent vorapaxar provides effective long-term secondary prevention of cardiovascular events and stroke in this subgroup.

“Our data raise the possibility that vorapaxar [Zontivity; Merck Sharp & Dohme], which inhibits platelets via a pathway separate from that of aspirin and P2Y12 inhibitors. . . offers a particular advantage for patients with [diabetes],” write David A. Morrow, MD, MPH, of Brigham and Women’s Hospital (Boston, MA), and colleagues. Vorapaxar inhibits PAR-1, the predominant receptor for thrombin on the surface of platelets. Take Home: Vorapaxar Effective for Secondary Prevention in Diabetic Patients With Prior MI

The TRA 2°P-TIMI 50 study included 26,449 patients with stable atherosclerosis who were randomized to receive standard care, including aspirin, and either vorapaxar (2.5 mg daily) or placebo at 1,032 sites in 32 different countries. It demonstrated a reduction in the composite of cardiovascular death, MI, or stroke at 3 years with vorapaxar vs placebo. . . .

Well. . . it will still never be a blockbuster, in my opinion -- but it may break the $200 million a year mark -- for peak sales, at some point, now. Just my newly revised guess, here.

A Second BioSimilar Player Launches In The EU Next Week -- Merck's Remicade® To Be Mightily Pressured In EU

We have long reported that both Celltrion and Hospira (soon to be a part of Pfizer) possess the requisite approvals in the EU to launch their respective biosimilars. [Additional backgrounder, here.]

The legacy Schering-Plough (and J&J -- by license/distribution agreement settlement proceedings) patents in the EU formally expire next week, on the 25th -- and so Celltrion will launch that following morning. Of course in the 2010 spat settlement, J&J gave Merck the EU rights -- so this will not affect J&J immediately. This -- over time -- will actually be material to Merck. However, it is well-factored into the NYSE price at present. Here is a bit of the report from BioPharma-Reporter; do go read it all:

. . . .The South Korean drugmaker told delegates at the European Crohn’s and Colitis Organisation’s (ECCO) in Barcelona, Spain that Remsima could save the UK, Italy and France €336m ($413m) over the next five years. . . .

Celltrion told BioPharma-Reporter the predicted savings, which are based on its own analysis, will let national healthcare systems provide the treatment to more patients, sooner. . . .

As I say -- this has long been expected. But it presents very good news for the already strained Euro-zone payer health budgets. In most cases, that ultimately is a government entity, in the EU. So this is decidedly good news for patients -- and taxpayers, there. Onward.

Zwerko Guilty Plea Entered In Manhattan -- Along With Plea Agreement

Just to close this one out -- on May 15 the judge will enter his formal final sentence.

The involved statutes would allow a sentence of five to twenty. He is likely to be sentenced to three to four. So it ends -- with a whimper -- not a bang. From the online papers, then:

. . . .Zachary Zwerko pleaded guilty in Manhattan federal court to conspiring to commit securities fraud and three securities fraud counts. A plea agreement recommended a three to four-year prison sentence.

Assistant U.S. Attorney Jessica Masella said the 32-year-old Cambridge, Massachusetts, resident passed along secrets that earned $722,000 in illegal profits. . . .

A more material new post -- in mere moments. . . onward we go.

Thursday, February 19, 2015

Smallish Update: NewLink Genetics Gets $20 Million Milestone Deposit From Merck -- Large Ebola Vaccine Candidate Trial Underway In Sierra Leone

Completely immaterial to massive Merck, but good news for the Ames, Iowa NewLink folks.

Here's to hoping that they can get to a large enough wedge, to prove effectiveness. From the Genetic Engineering and BioTech News report then -- a bit:

. . . .NewLink Genetics said today it will receive $20 million from Merck & Co. for achieving a key clinical development milestone in their collaboration to co-develop the experimental Ebola vaccine candidate rVSV-EBOV—namely the launch of a large-scale clinical trial.

Earlier this month, NIH announced the launch of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), a Phase II/III study in which approximately 27,000 healthy men and women aged 18 years and older are being assessed for their response following assignment at random to placebo or any of two Ebola vaccine candidates—rVSV-EBOV, and cAd3-EBOZ. . . .

Onward! And we send our very best wishes -- that it all works out. Whether it is one and done, or prime plus boost -- the planet will need to have it at the ready.

Tuesday, February 17, 2015

EU Approved Since 2013, Hospira Launched Inflectra® Biosimilar To Merck's Remicade® -- In EU Today

Well, we all knew this day was coming -- we said so, with specificity as to the date, back in September of 2014. And yet it has taken a bit of a spell to get all the ducks in a row, at Hospira.

The $2.4 billion a year Merck ex-US franchise will almost certainly see some near term and substantial erosion -- in the European Union in 2015. And Hospira -- the Abbott spinoff, just now being acquired by Pfizer -- will see a very strong revenue ramp on this product. So it goes. Here is the Zack's research note, on today's events -- across the pond:

. . . .Hospira announced that it has launched Inflectra® (infliximab), the first biosimilar monoclonal antibody, in major European markets. Inflectra is approved for inflammatory indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis and plaque psoriasis.

Inflectra is a biosimilar to the reference product, Johnson & Johnson/Merck’s (JNJ/MRK) Remicade (infliximab). Merck recorded Remicade revenues of $2.4 billion in 2014 in Europe, Russia and Turkey. . . .

More background here (for more, dozens more, search "Remicade" in the upper left box). And. . . I am sure ole' Bob Parkinson is glaring at not so old Ian Read now. But Mr. Frazier is likely unruffled -- by either of them.

Monday, February 16, 2015

Another Large Holder Added Incrementally To Its Merck Stockholdings, In 2014

Various Capital New World entities have been steady large holders for over a decade, in Merck (and in legacy Schering-Plough as well). During the year 2014, they inched upward, almost touching the six per cent of outstanding mark once again (click image at right to embiggify!).

I suppose it is also significant (and encouraging) that they've actually added nearly 1.8 million Merck shares -- to their holdings. Still not back to the 2010 high water mark levels, but moving in the right direction, certainly. From the just filed SEC Schedule 13G amendment, then:

. . . .PERCENT OF CLASS. . . 5.9%

SOLE DISPOSITIVE POWER | 170,766,040 Shares. . . .

Onward, then. . . enjoying a quiet Presidents' Day -- here in the US. . .

Saturday, February 14, 2015

Closing Out A Sad 2008-2010 Chapter: Last Inside Trader From Former SGP/MRK To Plead Out, Per His Lawyer

I post this not because it should in any way reflect upon the current "new" Merck, and its generally hard-working, ethical, honest and very capable team of employees and officers, worldwide. [No. . . this is just a sad reminder of the CEO Fred Hassan-led past, only.]

I post it to complete the record -- and close this unfortunate chapter out. It seems that the last of the 2008-2010 era inside trading ex-SGP (and, to a lesser extent, ex-MRK) employees will be sentenced on an agreed plea later this month. Here is some of the background (do search "insider trading", in my search box, upper left, for the full 20-plus posts download), and here is a Reuters story on the rumored plea, from earlier this week:

. . . .A former Merck & Co Inc finance analyst plans to plead guilty to engaging in an insider trading scheme by tipping a former Bank of New York Mellon Corp employee about potential pharmaceutical mergers, his lawyer said on Monday.

Zachary Zwerko is in the process of negotiating a plea agreement to resolve the conspiracy and securities charges he faces, his lawyer, Jeffrey Denner, confirmed after a court hearing in Manhattan federal court. . . .

More local 2010 color here. May the passion of St. Valentine burn brightly -- for all of us, today!